Pet food composition for managing non-food allergies

ABSTRACT

A food composition for managing non-food allergies in companion animals is disclosed, along with a method of managing non-food allergies.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/235,082, filed on Sep. 30, 2015. The disclosure of the aboveapplication is incorporated herein by reference.

BACKGROUND

Approximately 15-25% of all small animal veterinary practice activity isdevoted to problems related to the skin and coat of dogs and cats (SmallAnimal Clinical Nutrition 5th Edition p. 637). Allergies in pets can becaused by foods (chicken, beef, dairy, soy, etc.) and by non-food causesincluding environmental elements like pollens, dusts, molds, mites, fleabites, etc. (“environmental allergies”). Among pets with allergies,approximately 80% have environmental allergies, and 20% have foodallergies. For pets with food allergies, diets are commonly availablethat lack specific ingredients known to cause allergic reactions, e.g.,chicken or beef.

Currently, a typical treatment for dogs displaying symptoms ofenvironmental allergies includes the administration of steroids,anti-histamines, baths/dips, and/or nutritional supplements. There is aneed for a less invasive, more natural approach to relieving thesymptoms of environmental allergies. The invention addresses this needwith a highly palatable and easy to feed food composition.

BRIEF SUMMARY

The invention is directed to a pet food composition for managingnon-food allergies. The pet food composition comprises a combination ofnutrients, including omega-6, omega-3, omega-9, alpha lipoic acid,quercetin sources including selected herbs, fruits and vegetables, eggproduct and vitamin E and C. Further, the invention is directed to theuse of a pet food composition in managing non-food allergies incompanion animals as part of a treatment regimen.

In an embodiment, compositions for managing non-food allergies in acompanion animal are provided comprising: one or more omega-3 fattyacids, one or more omega-6 fatty acids, and one or more omega-9 fattyacids, in relative amounts to produce a total omega-3 to total omega-6fatty acid to total omega-9 fatty acid ratio of from about 0.5:2.0:2.0to about 3.0:5.0:5.0, and a total omega-6 fatty acid content of fromabout 1.5 percent by weight to about 12 percent by weight; from 0.1percent by weight to 15 percent by weight of egg product; andalpha-lipoic acid; polyphenol; Vitamin C and Vitamin E are present intherapeutic non-zero amounts, wherein all percentages by weight arebased on total dry weight.

In an embodiment, compositions for managing non-food allergies in acompanion animal are provided comprising: one or more omega-3 fattyacids, one or more omega-6 fatty acids, and one or more omega-9 fattyacids, in relative amounts to produce a total omega-3 to total omega-6fatty acid to total omega-9 fatty acid ratio of from about 0.9:2.0:2.0to about 3.0:5.0:5.0, and a total omega-6 fatty acid content of fromabout 1.5 percent by weight to about 12 percent by weight; from 0.01percent by weight to 0.12 percent by weight alpha-lipoic acid; from 0.1percent by weight to 15 percent by weight of egg product; from 200 IU/kgto 1,300 IU/kg Vitamin E; from 30 ppm to 750 ppm Vitamin C; and from 1.5ppm to 50 ppm polyphenol; wherein, all percentages by weight are basedon total dry weight.

Another embodiment provides a method for managing allergies to non-foodallergens in a companion animal comprising feeding the animal during aninduction period prior to exposure of the animal to the non-foodallergen with a food composition comprising: one or more omega-3 fattyacids, one or more omega-6 fatty acids, and one or more omega-9 fattyacids, in relative amounts to produce a total omega-3 to total omega-6fatty acid to total omega-9 fatty acid ratio of from about 0.9:2.0:2.0to about 3.0:5.0:5.0, and a total omega-6 fatty acid content of fromabout 1.5 percent by weight to about 12 percent by weight; from 0.01percent by weight to 0.12 percent by weight alpha-lipoic acid; from 0.1percent by weight to 15 percent by weight of egg product; from 200 IU/kgto 1,300 IU/kg Vitamin E; from 30 ppm to 750 ppm Vitamin C; and from 1.5ppm to 50 ppm polyphenol; wherein, all percentages by weight are basedon total dry weight.

An embodiment provides a kit for managing non-food allergies in acompanion animal comprising two or more ingredients that, when combinedtogether and optionally with additional ingredients that are not a partof the kit, yield a composition that comprises: one or more omega-3fatty acids, one or more omega-6 fatty acids, and one or more omega-9fatty acids, in relative amounts to produce a total omega-3 to totalomega-6 fatty acid to total omega-9 fatty acid ratio of from about0.9:2.0:2.0 to about 3.0:5.0:5.0, and a total omega-6 fatty acid contentof from about 1.5 percent by weight to about 12 percent by weight; from0.01 percent by weight to 0.12 percent by weight alpha-lipoic acid; from0.1 percent by weight to 15 percent by weight of egg product; from 200IU/kg to 1,300 IU/kg Vitamin E; from 30 ppm to 750 ppm Vitamin C; andfrom 1.5 ppm to 50 ppm polyphenol; wherein, all percentages by weightare based on total dry weight.

A further embodiment provides use of a composition that comprises: oneor more omega-3 fatty acids, one or more omega-6 fatty acids, and one ormore omega-9 fatty acids, in relative amounts to produce a total omega-3to total omega-6 fatty acid to total omega-9 fatty acid ratio of fromabout 0.9:2.0:2.0 to about 3.0:5.0:5.0, and a total omega-6 fatty acidcontent of from about 1.5 percent by weight to about 12 percent byweight; from 0.01 percent by weight to 0.12 percent by weightalpha-lipoic acid; from 0.1 percent by weight to 15 percent by weight ofegg product; from 200 IU/kg to 1,300 IU/kg Vitamin E; from 30 ppm to 750ppm Vitamin C; and from 1.5 ppm to 50 ppm polyphenol; wherein, allpercentages by weight are based on total dry weight to prepare a foodfor managing non-food allergies in a companion animal. This may be aspart of a treatment regimen, for example, prescribed by a veterinarian.

Further, the invention is directed to the use of a pet food compositionin managing non-food allergies in companion animals and means forcommunicating the use.

Further areas of applicability of the present invention will becomeapparent from the detailed description provided hereinafter. It shouldbe understood that the detailed description and specific examples, whileindicating the preferred embodiment of the invention, are intended forpurposes of illustration only and are not intended to limit the scope ofthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more fully understood from thedetailed description and the accompanying drawings, wherein:

FIG. 1 is a graph of the Mean Skin Health Scores from Example 2.

FIG. 2 is a graph of the Mean Pruritus Scores from Example 2.

FIG. 3 presents graphs of the results of Example 3, depicting thebaseline results and after 29 days of feeding for Skin ErythemaIntensity in dogs with atopic dermatitis.

FIG. 4 presents a graph which shows the IL-12p40 results of Example 3.

FIG. 5 presents a graph which shows the IL-2 results of Example 3.

FIG. 6 presents a graph which shows the MCP-1 results of Example 3.

DETAILED DESCRIPTION

The following description of the preferred embodiment(s) is merelyexemplary in nature and is in no way intended to limit the invention,its application, or uses.

As used throughout, ranges are used as shorthand for describing each andevery value that is within the range. Any value within the range can beselected as the terminus of the range. In addition, all references citedherein are hereby incorporated by referenced in their entireties. In theevent of a conflict in a definition in the present disclosure and thatof a cited reference, the present disclosure controls.

Unless otherwise specified, all percentages and amounts expressed hereinand elsewhere in the specification should be understood to refer topercentages by weight. The amounts given are based on the active weightof the material.

The invention is directed to a food composition comprising a combinationof nutrients effective in reducing skin redness, repairing skin,improving hair texture and reducing hair oiliness. In addition, the foodcomposition is effective in reducing itching in pets that exhibitsymptoms related to environmental allergies, and can delay the onset ofclinical signs or reduce the severity of clinical signs if thecomposition is administered before a companion animal is exposed toenvironmental allergens. The recurrence rate for seasonal atopicdermatitis is high. Therefore, the identification of periods when dogswill be vulnerable can be established based upon an understanding oftheir past seasonal experiences.

Atopic dermatitis is an inflammatory, chronic skin disease associatedwith allergies, triggered by non-topical allergen insult, such as polleninhalation. The term atopic is used to indicate it does not arise fromdirect topical contact exposure of the inflamed area to the allergen.Allergic contact dermatitis may result from direct skin exposure to theallergen. Symptoms of dermatitis in dogs include pruritus,lichenification, excoriation, erythema and alopecia. Observablebehaviors in dogs suffering from dermatitis include itching, licking,rubbing and scratching.

Pruritus is the medical term for itching. It is common in many types ofskin disorders. Lichenification describes the presence of thick,leathery skin, usually the result of constant scratching and rubbing.Lichenification is a common consequence of atopic dermatitis and otherpruritic (itchy) disorders. With prolonged rubbing or scratching, theouter layer of the skin (the epidermis) becomes hypertrophied(overgrown) and this results in thickening of the skin and exaggerationof the normal skin markings, giving, the skin a leathery bark-likeappearance. Excoriation is a term used to describe skin damage/removalas a result of excessive scratching, or biting, at the itchy area ofskim. Erythema multiforme is a skin condition that is characterized byraised spots or other skin lesions. Alopecia is the loss of hair, whichmay result from skin irritation.

Early intervention in canine atopic dermatitis results in improved meanpeak skin health and pruritus scores. Incorporating the food accordingto the invention into a pre-treatment protocol, as part of a multimodalstrategy to manage dogs with atopic dermatitis, may result in delayed orreduced use of medication. In this exemplary method, food according tothe invention is fed to the animal during an induction period prior tothe expected exposure of the animal to the allergen. The inductionperiod can be from 1 week to 10 weeks, from 2 weeks to 8 weeks, from 3weeks to 6 weeks, optionally about 4 weeks.

Managing non-food allergies can comprise pre-treatment with nutrition inthe form of the food of the invention to support skin repair andreduction of immune response. Such pretreatment, along with frequentmonitoring for symptoms of non-food allergies, can limit and/or delaythe need for medications which may otherwise have been needed as a partof early intervention upon presentment of symptoms of non-food allergicresponse.

Nutritional management of canine atopic dermatitis helps the bodyprepare against the onslaught of antigens either within the home oroutside. This requires a building up and restoration of the skinbarrier, and reduction of the over reactive response of the body toexternal antigens.

The food provided is a blend of fats and oils, whole egg, antioxidantsand sources of polyphenols formulated to help modulate the immuneresponse to allergens. The functional goal of the inclusion of thesenutrients is to help stabilize mast and inflammatory cells, therebydecrease histamine and cytokine release. Components within eggs havebeen shown to have immunomodulation and anti-oxidant activity amongother benefits.

Polyphenols have various interesting effect on the immune system. Forexample, flavonoids have anti-inflammatory and antioxidant activity, andalso can stabilize mast cells.

Nutritional management for canine atopic dermatitis inhibits theinflammatory response, stabilizes the skin barrier and supports skin andcoat health. Invisible inflammation is present in patients who have skinbarrier dysfunction and can be addressed using nutrition andpharmaceuticals. Unhealthy skin, including the ear canal, can beaddressed externally through the use of topical anti-inflammatorymedications and gentle cleansing. Unhealthy skin can also be addressedthrough nutrition to support healing and growth of a strong, resilienthair coat.

Plant based foods such as green tea, fruits, some herbs and greenvegetables are rich in polyphenols which act as antioxidants, induceantioxidant enzymes such as glutathione peroxidase and superoxidedismutase and have been found to modulate cell signaling pathways. Inhuman and laboratory animal studies, polyphenols have been found to playan inhibiting role in the presentation of allergens to the immune systemand an inhibitory role in T cell release of cytokines, inhibition of Bcell production of IgE and inhibition of degranulation by mast cells. Inaddition, polyphenols have anti-oxidant activity limiting the freeradical cellular injury which may occur during allergic insults.

Vitamin E, antioxidants and omega-3 fatty acids also play a role.Vitamin E plays a vital role in protecting skin lipids from peroxidationsecondary to exposure to UV radiation, inflammation or infection.Dietary alpha tocopherol increases serum vitamin E levels and serumvitamin E correlates with skin levels of vitamin E. The food accordingto the invention contains vitamin E in excess of the above recommendedamount and also contains other anti-oxidant sources including vitamin C,green tea as source of catechins and lipoic acid.

Gene expression and metabolic pathway analysis are useful techniques toidentify ingredients and nutrients which positively affect pathways ofinterest for a particular disease. Metabolic pathway analysis usescomplex modeling of network-based pathways to interpret gene expressionand metabolite data. In the exemplary case of canine atopic dermatitis,we identified ingredients that target inflammation, the immune systemand histamine related pathways. Therefore, the food may also containbeneficial fats and complex carbohydrate sources shown in cell culturestudies to have a positive effect on metabolic pathways associated withinflammation, the immune system and histamine.

Achieving healthy skin and hair coat requires a complex balance of macroand micronutrients. Protein, Vitamins E, omega-3 and omega-6 fatty acidsand their ratio to one another, and minerals such as zinc and copper allcontribute to growth and healing of the epidermis, dermis, collagen andpigmentation. Both omega-6 and omega-3 fatty acids play important rolesin skin and systemic health. The essential fatty acids, cis-linoleic andalpha-linolenic represent omega-6 and omega-3 fatty acid familiesrespectively. In companion animal atopic dermatitis, both omega-6 andomega-3 fatty acids are important in skin healing and its resistance toproducing inflammatory cytokines in the face of allergic insult. It iswell known that omega-3 fatty acids result in less inflammatorycytokines and as the relative amount of omega-3 fatty acids in the dietincreases, more prostaglandins of the 3 series and leukotrienes of the 5series are produced in cells. Omega-9 fatty acids are thought to impactsignaling cascades that affect inflammation and cell growth.

The combination of nutrients in the pet food, according to an embodimentof the invention, includes (all percentages express weight percent basedon total dry food weight, unless otherwise specified):

Total dietary fat levels from sources like chicken, pork, and/or beeffat, of from 8% to 25%, from 10% to 20%, from 11% to 19%, from 12% to18%, from 13% to 17%, from 14% to 16%;

Omega 3, 6 and 9 fatty acids are present in a ratio of from 0.5:2.0:2.0to 3.0:5.0:5.0, from 0.7:2.0:2.0 to 1.2:2.0:2.0; optionally about0.8:2.0:2.0 to 1.1:2.0:2.0, optionally about 0.9:2.0:2.0 to 1.0:2.0:2.0.The fatty acids come from sources like soybean oil, flaxseed, chickenfat, pork fat, beef fat, olive oil, sunflower oil, corn oil, coconutoil, and/or fish oil. Fatty acids are long carbon chains with a methylgroup at one end. Polyunsaturated fatty acids have multiple doublebonds. The fatty acids that have the first double bond three carbonsaway from the methyl group are the omega-3 (or n-3) series. The omega-6(or n-6) series of polyunsaturated fatty acids have the first doublebond six carbons from the methyl group. Inmammals, polyunsaturatedornega-3 and omega-6 fatty acids are essential fatty acids(“EFAs”)because they cannot be synthesized de novo by mammals. Membersof the omega-6 family include, for example, linoleic (18:211-6),gamma-linolenic (18:311-6), dihomogammalinolenic (20:311-6), andarachidonic acid (20:411-6). Members of the omega-3 family include, forexample, alpha-linolenic (18:3n-3), eicosatetraenoic (20:4n-3),eicosapentaenoic (20:5n-3), and docosahcxaenoic acid (22:6n-3). In theskin, EFAs are principally found in phospholipids. The high degree ofunsaturation of EFAs bestows fluidity to phospholipids at physiologictemperatures, allowing conformational changes to occur. One of theskin-related functions of EFAs is the incorporation of linoleic acidinto the ceramides of the lipid portion of the epidermal cornifiedenvelope. This envelope serves a barrier function to prevent loss ofwater and other nutrients. EFAs are a source of energy for the skin andserve as precursors to a variety of potent, short-lived moleculesincluding prostaglandins, leukotrienes, and their metabolites. In someembodiments, the composition comprises an amount of linoleic acid thatis equal to or higher than the minimum allowance recommended by theAssociation of American Feed Control Officials (“AAFCO”). In someembodiments, the composition comprises an amount of linoleic acid thatis up to about 200% higher, up to about 300% higher, up to about 400%higher, up to about 500% higher, up to about 600% higher, up to about700% higher, up to about 800% higher, up to about 900% higher, up toabout 1000% higher, or up to about 1100% higher than the respectiveAAFCO minimum allowance. The AAFCO's minimum linoleic acid allowance forgrowth, reproduction, and maintenance of dogs is 1% on a dry matterbasis (presuming that the energy density of the diet is 3.5 kcal ME/gdry matter). Therapeutic non-zero amounts of various ingredients cangenerally be determined by reference to such dietary guidelines andother materials within the general knowledge of food scientists andveterinary practitioners. In some embodiments:

The amount of egg product, such as dried egg present is from 0.1% to15%, from 0.2% to 14%, from 0.3% to 13% from 0.4% to 12%, from 0.5 to11%, from 0.7 to 10%, from 0.8% to 9%, from 0.9% to 8%, from 1% to 7%,from 2% to 6%, from 3% to 5%.

The amount of Vitamin E present is from 200 IU/kg to 1,300 IU/kg, from300 IU/kg to 1,200 IU/kg, 400 IU/kg to 1,100 IU/kg, from 500 IU/kg to1,000 IU/kg, from 600 IU/kg to 800 IU/kg.

The amount of Vitamin C present is from 30 ppm to 750 ppm, from 50 ppmto 700 ppm, from 75 ppm to 600 ppm, from 100 ppm to 500 ppm.

The amount of dietary polyphenol, such as quercetin present is from 1.5ppm to 50 ppm, from 3 ppm to 40 ppm, from 4 ppm to 30 ppm, from 5 ppm to25 ppm, from 8 ppm to 20 ppm, from 10 ppm to 15 ppm.

Quercetin sources include green tea extract, pea powder, apple powder,cranberry powder, carrot powder, broccoli powder, rosemary extract,citrus extract, schinopsis extract, eugenia extract, and curcumaextract.

The food composition includes dry and wet (loaf, minced, stew)compositions, including nutritionally complete diets, snacks and treats.

In another aspect, the present invention provides an article ofmanufacture, such as for example a kit comprising elements which can beassembled to form the composition. In some embodiments, the kitcomprises in separate containers in a single package or in separatecontainers in a virtual package, as appropriate a composition of thepresent invention or two or more ingredients, that, when combinedtogether and optionally with additional ingredients that are not a partof the kit, yield a composition comprising one or more omega-3 fattyacids, one or more omega-6 fatty acids, and one or more omega-9 fattyacids, in relative amounts to produce a total omega-3 to total omega-6fatty acid to total omega-9 fatty acid ratio of from about 0.9:2.0:2.0to about 3.0:5.0:5.0, and a total omega-6 fatty acid content of fromabout 1.5 percent by weight to about 12 percent by weight; from 1percent by weight to 12 percent by weight alpha-lipoic acid; from 0.1percent by weight to 15 percent by weight of egg product; from 200 IU/kgto 1,300 IU/kg Vitamin E; from 30 ppm to 750 ppm Vitamin C; and from 1.5ppm to 50 ppm polyphenol; wherein, all percentages by weight are basedon total dry weight and at least one of (1) instructions for feeding thecomposition to an animal, (2) instructions for making a composition ofthe present invention by combining the two or more ingredients, (3) oneor more agents for managing non-food allergies, and (4) instructions foradministering the agents in conjunction with the composition. The term“single package” generally means that the components of a kit arephysically associated in or with one or more containers and consideredas a unit of manufacture, distribution, sale, or use.

Containers include, but are not limited to, bags, boxes, bottles, cans,shrink wrap packages, stapled or otherwise fixed components, orcombinations thereof. A single package can be, for example, containersor individual food compositions physically associated such that they areconsidered a unit for manufacture, distribution, sale, or use. The term“virtual package” generally means that the components of a kit areassociated by directions on one or more physical or virtual kitcomponents instructing the user how to obtain additional components,e.g., in a bag containing one component and directions instructing theuser to go to a website, contact a recorded message, view a visualmessage, or contact a caregiver to obtain instructions on how to use thekit. When the kit comprises a virtual package, the kit is limited toinstructions in a virtual environment with one or more physical kitcomponents.

In another aspect, the present invention provides a means forcommunicating information about or instructions for one or more of (1)using a composition of the present invention for managing non-foodallergies, (2) using a composition of the present invention inconjunction with one or more agents for improving skin health, improvingpelage quality, and/or promoting the health or wellness of an animal,and (3) using a kit of the present invention for managing non-foodallergies comprising a document, digital storage media, optical storagemedia, audio presentation, a web app, or visual display containing theinformation or instructions. In certain embodiments, the communicatingmeans comprises a document, digital storage media, optical storagemedia, audio presentation, or visual display containing the informationor instructions. Preferably, the communication means is a displayed website, a web app, or a brochure, product label, package insert,advertisement, or visual display containing such information orinstructions. Useful information or instructions include, for example,(1) information and instructions how to use a composition, method, orkit of the present invention and (2) contact information for animalcaregivers if they have a question about the invention and its uses.

In one embodiment the pet food composition, as described herein, may beprescribed by a veterinarian as part of a treatment regimen. In afurther embodiment, the veterinarian or pet owner may track the efficacyof the treatment regimen through observation and/or other monitoring,such as a wearable device on dogs which monitors behaviors associatedwith allergies, for use in combination with the food according to theinvention.

EXAMPLES Example 1

A double blind study was performed to determine the impact of a testfood (T) comprising ingredients designed to have immune modulatingeffects on seasonal atopy versus a control food (C). Dogs with a historyof, but without current clinical signs of seasonal atopy were recruitedin the spring from general veterinary practices in the United States.Dogs currently on foods designed for adverse food reactions or that hadundergone desensitization therapy were excluded. Eligible dogs wererandomly assigned to the T or C groups, and evaluated by theirveterinarian at 0, 4, 8, 12 and 16 weeks. Medications prescribed, anddosing information was collected. Only oclacitinib, which was notuniformly available, was disallowed during the study.

Veterinarians scored for pruritus (0-none to 4-severe) and a used a skinscore visual atlas to grade 27 regions (0-none to 4-severe) forerythema, lichenification, excoriation and alopecia. Dogs withincomplete data, without clinical signs, or a CADESI >0 or at baseline,were eliminated from the data set. Thirty-six dogs (19 T, 16 C) wereincluded in the final analysis. Medications were administered to 15/16(93.75%) of C vs. 13/19 (68.42%)% of T dogs. Most commonly, a topicalcontaining a glucocorticoid, systemic antihistamine, a systemicglucocorticoid and/or a systemic immunomodulator was administered. Asurvival analysis was performed considering time until first prescribedday for topical (99±6.5 d C, 93.6±8.8 d T) medications, antihistamine(54.3±3.8 d C, 60.2±5.2 d T) and systemic glucocorticoids (83.2±8.1 d C,102.6±5.6d T). As shown in Table 1 below, results were similar fortopical medications and were numerically lower for both systemicmedications in treated dogs. Fewer Test food fed dogs received each typeof medication—topical (44% C, 42% T), antihistamine (44% C, 26%T),systemic glucocorticoids (50% C, 37% T) and systemic immunomodulator(6% C, 0% T). Overall fewer test food fed dogs received any medication(93.75% C, 68.42% T). The test food contributed to delayed and decreasedmedical intervention.

TABLE 1 Medication Data Systemic Immuno- Systemic Topical Systemicmodulator anti- gluco- gluco- (cyclo- Food Patient histamine corticoidcorticoid sporine) Control C84-DT-003-P YES Control C84-EH-002-P YES YESControl C84-KR-005-P YES Control C84-KR-008-P YES YES ControlC84-KR-010-P YES Control C84-KR-011-P YES Control C84-LB-002-P YESControl C84-LB-007-P YES YES Control C84-LB-010-P YES ControlC84-LB-013-P YES YES YES Control C84-MP-010-P YES YES ControlC84-MP-012-P YES YES Control C84-MP-014-P YES YES Control C84-SH-009-PYES Control C84-SH-011-P Control C84-SR-005-P YES Percentage n =16  44%%44% 50% Overall Percentage 15/16 = 94.75% Test C84-DK-002-P YES YES TestC84-DT-004-P Test C84-DT-005-P YES Test C84-DT-007-P Test C84-DT-012-PYES Test C84-DT-013-P YES Test C84-EH-001-P YES YES Test C84-EH-003-PYES Test C84-KR-006-P YES YES Test C84-KR-007-P YES Test C84-LB-006-PYES YES Test C84-LB-008-P YES YES Test C84-MP-008-P YES TestC84-MP-017-P YES YES YES Test C84-RS-008-P Test C84-RS-010-P TestC84-SG-002-P Test C84-SH-003-P YES Test C84-SR-004-P Percentage n = 1926% 42% 37% 0% Overall Percentage 13/19 = 68.42%

Example 2

A case series was performed to determine the impact of the foodcomposition according to the present invention on clinical signs ofseasonal atopy. Dogs with a history of and current clinical signs ofatopy were recruited from general veterinary practices in the UnitedStates and evaluated by their veterinarian and owner at 0, 4 and 8weeks. Medications could be prescribed except oclacitinib, which was notuniformly available. Veterinarians scored for pruritus and a used amodified CADESI to grade 27 body regions (0-none to 4-severe). Ownersevaluated atopy related behaviors with a visual scale of “none” to “allof the time.” The continuum was converted to a 0-100 score and answeredquestions concerning hair coat and skin. Twenty out of 27 enrolled dogscompleted the study; 7 were dismissed for compliance (5) ordiarrhea/acceptance (2). Medication was administered to 19/20 dogs, mostcommonly topical with a glucocorticoid, systemic antihistamine and/or aglucocorticoid was administered. At 8 weeks, 75% had a lower CADESI, 15%increased and 75% had decreased pruritus, 5% increased (Tables 2, 3 and4

Example 2A

FIGS. 1 and 2 illustrate the surprising improvement in Total Skin Healthand Pruritus Scores from dogs enrolled in the studies outlined inExample 1 and Example 2. Peak skin and pruritus scores in the Example 1study were lower for dogs consuming the food invention and dogs in bothstudies showed improvement. Dogs in Example 1 received pretreatment withfood of the invention as part of multimodal therapy (n =19) versus 20dogs that were started on the food as part of multimodal therapy afterbecoming symptomatic as described in Example 2.

TABLE 2 Total CADESI (Canine Atopic Dermatitis Extent and Severity IndexScore) Visit Screening Week 4 Week 8 Patient ID n-20 n = 20 n = 20C84-DT-001-S 4 4 12 C84-DT-002-S 9 0 2 C84-KR-001-S 11 9 4 C84-KR-002-S58 12 50 C84-KR-004-S 8 0 0 C84-MP-002-S 0 0 0 C84-MP-003-S 5 6 2C84-MP-005-S 24 23 2 C84-MP-006-S 68 71 4 C84-MP-007-S 7 6 1C84-MP-015-S 81 51 34 C84-RS-005-S 11 25 8 C84-RS-006-S 65 49 30C84-RS-007-S 2 1 2 C84-SH-001-S 3 10 10 C84-SH-005-S 8 0 2 C84-SH-006-S34 16 5 C84-SH-007-S 6 0 2 C84-SH-008-S 12 6 13 C84-SR-003-S 18 14 0Mean: 21.70 15.15 9.15 StdDev: 25.28 19.88 13.46 Week 4 Week 8 Increased 4 (20%)  3 (15%) Decreased 14 (70%) 15 (75%) Same  2 (10%)  2 (10%)

TABLE 3 Pruritus score per animal per visit. Visit Screening Week 4 Week8 Patient ID n-20 n = 20 n = 20 C84-DT-001-S 2 2 2 C84-DT-002-S 3 1 1C84-KR-001-S 3 2 1 C84-KR-002-S 3 1 3 C84-KR-004-S 2 0 0 C84-MP-002-S 32 3 C84-MP-003-S 2 1 1 C84-MP-005-S 3 2 0 C84-MP-006-S 3 3 1C84-MP-007-S 2 2 1 C84-MP-015-S 4 3 2 C84-RS-005-S 2 2 1 C84-RS-006-S 33 2 C84-RS-007-S 1 1 1 C84-SH-001-S 1 3 2 C84-SH-005-S 2 1 0C84-SH-006-S 3 2 0 C84-SH-007-S 1 1 0 C84-SH-008-S 3 2 2 C84-SR-003-S 32 1 Mean: 2.45 1.80 1.20 StdDev: 0.83 0.83 0.95 Week 4 Week 8 Increased1 (5%) 1 (5%) Decreased 12 (60%) 15 (75%) Same  7 (35%)  4 (20%)

TABLE 4 Erythema Score Per Animal Per Visit Visit Screening Week 4 Week8 Patient ID n-20 n = 20 n = 20 C84-DT-001-S 4 4 9 C84-DT-002-S 4 0 1C84-KR-001-S 9 3 2 C84-KR-002-S 22 2 22 C84-KR-004-S 6 0 0 C84-MP-002-S0 0 0 C84-MP-003-S 5 6 2 C84-MP-005-S 5 4 0 C84-MP-006-S 24 28 4C84-MP-007-S 5 4 1 C84-MP-015-S 28 4 4 C84-RS-005-S 6 13 4 C84-RS-006-S30 19 8 C84-RS-007-S 2 1 2 C84-SH-001-S 2 3 2 C84-SH-005-S 8 0 2C84-SH-006-S 13 2 1 C84-SH-007-S 6 0 2 C84-SH-008-S 6 2 10 C84-SR-003-S9 4 6 Mean: 9.70 4.95 4.10 StdDev: 8.93 7.15 5.15 Week 4 Week 8Increased  4 (20%)  2 (10%) Decreased 14 (70%) 14 (70%) Same  2 (10%)  4(20%)

Veterinarian mean scores for other parameters are shown in Table 5 anddemonstrate improved scores for hair coat shine (Scale: 1-Extremely Dullto 7-Extremely Shiny), coat texture (1-Extremely Coarse or Brittle to7-Extremely Soft), shedding (1-Excessive to 5-None), skin healing(1-Poor to 5-Excellent), dander (1-Excessive to 5-None), hair regrowth(1-Poor-5-Excellent), overall coat quality (1-Poor to 5-Excellent) andoverall skin quality (1-Poor to 5-Excellent). The scoring rangesincluding qualitative descriptors for range endpoints are providedabove, and the numerical values appear in Table 5, below.

TABLE 5 Mean Score Veterinarian Range of Assessment Baseline Week 4 Week8 Responses Coat Shine 4.10 4.25 5.05 1 to 7 Coat Texture 4.70 4.65 5.201 to 7 Shedding 4.00 4.45 4.50 1 to 5 Skin Healing 2.33 2.14 3.56 1 to 5Dander 4.25 4.65 4.75 1 to 5 Hair Regrowth 2.13 2.00 3.11 1 to 5 OverallCoat Quality 3.00 3.00 3.55 1 to 5 Overall Skin Quality 2.80 3.05 3.35 1to 5

The majority of dogs had improved clinical signs (Table 6) as mean ownerscores improved for skin redness, itching and scratching, licking, headshaking, coat shine, face rubbing and pet's condition as disruptive; 65%of owners believed the food was somewhat to highly effective in reducinglicking and scratching and 70% wanted to continue feeding the new food.

TABLE 6 Pet Owner mean scores for signs of environmental allergies MeanScore Pet Owner 0-Extreme 100-None Question Baseline Week 1 Week 2 Week3 Week 4 Week 8 Skin Redness 57.9 64.7 75.4 75.6 75.9 74.5 Itching and39.6 44.2 56.4 53.8 54.0 59.1 scratching Licking 36.7 40.8 57.5 55.052.5 60.4 Head Shaking 67.1 70.1 76.4 79.3 78.6 78.9 Coat Shine 58.356.4 64.3 63.5 68.4 64.5 Face Rubbing 61.2 63.1 73.5 75.4 68.2 71.5 HowDisruptive 53.6 54.8 65.6 64.4 67.6 70.9 is Skin Condition

Example 3

Twenty five adult dogs (12 neutered males, 11 spayed females, 2 intactfemales, mean age 8.5 years) with a history of atopic dermatitis thatwere showing active signs of skin erythema were fed a complete andbalanced dry test dog food for 29 days. The test food contained 4% totalomega-6 fatty acids, 1.8% total omega-3 fatty acids, 900 IU/kg alphatocopherol on a dry matter basis as well as eggs and multiple botanicalingredients as sources of polyphenols all of which were intended toreduce systemic inflammation and immune system mediators in an effort toreduce skin irritation and redness in these dogs. Skin erythemaintensity was scored by a veterinarian at baseline and after 29 days offeeding the test food. Scores across 11 regions of each dogs' body weremade using a scale of 0=none, 1=mild, 2=moderate and 3=severe erythema.Food intake was measured daily, body weights were collected weekly, andblood samples for cytokine analysis were collected at baseline and onday 29. Food intake and body weight were unchanged during the feedingperiod. Mean skin erythema intensity score at baseline was 1.4indicating that overall skin erythema was mild to moderate in thesedogs, although some dogs had selected regions of their body with severeskin redness. As shown in FIG. 3, mean skin erythema intensity wassignificantly reduced to 1.1 (P<0.01) after 29 days of feeding with 16dogs (64%) showing a decline in skin erythema intensity score and 8 dogswith clinical skin redness at baseline that had no visible skin rednessafter consuming the test food. Cytokines analyzed were TNF-alpha,VEGF-A, IFN-gamma, NGF-beta, SCF, MCP-1, IL-2, IL-6, IL-8, IL-10, andIL-12p40. TNF-alpha, IFN-gamma, NGF-beta, IL-6 and IL-10 were belowassay detection limits. There were no significant changes from baselineto day 29 for VEGF-A, SCF and IL-8. FIGS. 4-6 present graphs of theresults, which shows that IL-12p40 was significantly lower (P=0.10) andMCP-1 and IL-2 were also lower compared to baseline. The test foodcontaining anti-inflammatory ingredients and antioxidants had agenerally positive effect in lowering pro-inflammatory cytokines andimportantly significantly reducing clinical signs of skin redness indogs with atopic dermatitis.

TABLE 7 Dry Food Formulation: Ingredient Composition % of of Test Foodformula Grains and fibers 59.8 Animal & vegetable 18.6 proteins Fats &oils* 9.3 Flavors & nutritional 5.8 balancing ingredients Dried egg**4.0 Minerals mixture 1.1 Fruits, vegetables, green 0.9 tea, lipoic acid,herb and spice extracts*** Vitamins mixture**** 0.7 Total 100 *(sourcesof omega-3, omega-6 & omega-9 fatty acids); **(source of egg product);***(source of polyphenols); ****(source vitamin E, vitamin C).

Ingredients:

Rice, Chicken Meal, Sorghum, Barley, Pea Protein, Eggs, Soybean Oil,Flaxseed, Chicken Liver Flavor, Oats, Beet Pulp, Fish Oil, Pork LiverFlavor, Lactic Acid, Chicken Fat, Potassium Chloride, Lipoic Acid,Choline Chloride, Salt, Vitamin E, Vitamin C, Niacin, Thiamine, VitaminA, Calcium Pantothenate, Vitamin B12, Pyridoxine Hydrochloride,Riboflavin, Biotin, Folic Acid, Vitamin D3, Calcium Carbonate, GreenPeas, Apples, Cranberries, Carrots, Ferrous Sulfate, Zinc Oxide, CopperSulfate, Manganous Oxide, Calcium Iodate, Sodium Selenite, Taurine, Herbextracts, Spice Extracts, Mixed Tocopherols, Broccoli, Beta-Carotene.

TABLE 8 Expressed on 100% dry matter Test Food Nutrient Content basisOverall nutrients Protein, % 23.0 Fat, % 15.2 Omega-3 Fatty Acids, % 1.8Omega-6 Fatty Acids, % 4.0 Omega-9 Fatty Acids, % 4.0 Ratio omega3:omega 6:omega 9 0.9:2:2 Vitamin E (alpha 1097 tocopherol), IU/kg CrudeFiber, % 1.7 Ash, % 5.7 Carbohydrate, % 54.4 Vitamin C 210 (ascorbicacid), ppm Alpha-lipoic Acid, ppm 166

What is claimed is:
 1. A composition for managing non-food allergies ina companion animal comprising: one or more omega-3 fatty acids, one ormore omega-6 fatty acids, and one or more omega-9 fatty acids, inrelative amounts to produce a total omega-3 to total omega-6 fatty acidto total omega-9 fatty acid ratio of from about 0.5:2.0:2.0 to about3.0:5.0:5.0, and a total omega-6 fatty acid content of from about 1.5percent by weight to about 12 percent by weight; from 0.1 percent byweight to 15 percent by weight of egg product; alpha-lipoic acid;quercetin; and Vitamin C and Vitamin E, wherein the Vitamin C and theVitamin E are present in therapeutic non-zero amounts, and wherein thequercetin is provided by quercetin sources comprising pea powder, applepowder, cranberry powder, and broccoli powder, wherein all percentagesby weight are on a dry matter basis of the composition.
 2. Thecomposition of claim 1, wherein the amount of the alpha-lipoic acid isfrom 0.01 percent by weight to 0.12 percent by weight.
 3. Thecomposition of claim 1, wherein the amount of the Vitamin E is from 200IU/kg to 1,300 IU/kg, and the amount of Vitamin C is from 30 ppm to 750ppm.
 4. The composition of claim 1, wherein the amount of the quercetinpresent is from 1.5 ppm to 50 ppm.
 5. The composition of claim 1,further comprising: from 0.01 percent by weight to 0.12 percent byweight alpha-lipoic acid; from 200 IU/kg to 1,300 IU/kg Vitamin E; from30 ppm to 750 ppm Vitamin C; and from 1.5 ppm to 50 ppm quercetin,wherein all percentages by weight are on a dry matter basis of thecomposition.
 6. The composition of claim 1, wherein the food has a totaldietary fat content of 8 percent by weight to 25 percent by weight. 7.The composition of claim 1, wherein the composition has a total omega-3to total omega-6 fatty acid to total omega-9 fatty acid ratio of about1.1 to about 2.0 to about 2.0.
 8. The composition of claim 1, whereinthe amount of the egg product is from 0.4 weight percent to 12 weightpercent.
 9. The composition of claim 1, wherein the amount of theomega-6 fatty acid is from 2 weight percent to 10 weight percent.
 10. Amethod for managing allergies to non-food allergens in a companionanimal comprising feeding the animal during an induction period prior toexposure of the animal to the non-food allergen with a food compositioncomprising: one or more omega-3 fatty acids, one or more omega-6 fattyacids, and one or more omega-9 fatty acids, in relative amounts toproduce a total omega-3 to total omega-6 fatty acid to total omega-9fatty acid ratio of from about 0.5:2.0:2.0 to about 3.0:5.0:5.0, and atotal omega-6 fatty acid content of from about 1.5 percent by weight toabout 12 percent by weight; from 0.01 percent by weight to 0.12 percentby weight alpha-lipoic acid; from 0.1 percent by weight to 15 percent byweight of egg product; from 200 IU/kg to 1,300 IU/kg Vitamin E; from 30ppm to 750 ppm Vitamin C; and from 1.5 ppm to 50 ppm quercetin, whereinthe quercetin is provided by quercetin sources comprising pea powder,cranberry powder, and broccoli powder, and wherein all percentages byweight are on a dry matter basis of the composition.
 11. The compositionof claim 1, wherein the quercetin sources further comprise carrotpowder.
 12. The composition of claim 11, wherein the quercetin sourcesconsist of the pea powder, the apple powder, the cranberry powder, thebroccoli powder, and the carrot powder, and wherein the total omega-3 tototal omega-6 fatty acid to total omega-9 fatty acid ratio is about0.9:2:2.
 13. The method of claim 10, wherein the food has a totaldietary fat content of 8 percent by weight to 25 percent by weight. 14.The method of claim 10, wherein the composition has a total omega-3 tototal omega-6 fatty acid to total omega-9 fatty acid ratio of about 1.1to about 2.0 to about 2.0.
 15. The method of claim 10, wherein theamount of the egg product is from 0.4 weight percent to 12 weightpercent.
 16. The method of claim 10, wherein the amount of the omega-6fatty acid is from 2 weight percent to 10 weight percent.
 17. The methodof claim 10, further comprising monitoring the animal to detect symptomsof non-food allergies.
 18. A kit for managing non-food allergies in acompanion animal comprising two or more ingredients that, when combinedtogether, yield a composition that comprises: one or more omega-3 fattyacids, one or more omega-6 fatty acids, and one or more omega-9 fattyacids, in relative amounts to produce a total omega-3 to total omega-6fatty acid to total omega-9 fatty acid ratio of from about 0.5:2.0:2.0to about 3.0:5.0:5.0, and a total omega-6 fatty acid content of fromabout 1.5 percent by weight to about 12 percent by weight; from 0.01percent by weight to 0.12 percent by weight alpha-lipoic acid; from 0.1percent by weight to 15 percent by weight of egg product; from 200 IU/kgto 1,300 IU/kg Vitamin E; from 30 ppm to 750 ppm Vitamin C; and from 1.5ppm to 50 ppm quercetin; wherein the quercetin is provided by quercetinsources comprising pea powder, apple powder, cranberry powder, andbroccoli powder, and wherein, all percentages by weight are on a drymatter basis of the composition.
 19. The kit of claim 18, wherein thekit further comprises one or more agents for managing non-food allergiesin a companion animal.
 20. The kit of claim 19, further comprising oneor more of instructions for making the composition by combining the twoor more ingredients, instructions for feeding the composition to theanimal, and instructions for administering the agents in conjunctionwith the composition.